Effectiveness of Virtual Bodily Illusion Intervention in Upper Limb Motor Function, Sensibility and Pain in People With Incomplete Spinal Cord Injury.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Range of motion of elbow
研究概览
简要总结
Previous studies have shown that the neuroplasticity of the residual corticospinal fibers, the motor cortex and the spinal neurons plays an important role in the spontaneous functional recovery of people with neurological or musculoskeletal pathology. However, it is also possible to stimulate the neuroplasticity mechanisms of these structures through techniques aimed at rehabilitating different deficits (for example, motor function or sensitivity). In general, intervention programs are usually carried out, in most cases, using low-cost strategies such as therapeutic physical exercise programs.
The objective of this study is to analyze the effectiveness of visual illusion therapies in combination with conventional exercises on the symptoms and signs related to incomplete spinal cord injury that affects the upper limb.
The study will include the realization of three measurements that will be carried out one day before starting the program, one day after finishing it, and one month later (follow-up).
The clinical assessment will be composed of the study of the following variables: Motor function and motor skills, Upper limb isometric force, Muscle activation, Muscle tone, Quality of life, Functionality. All interventions will last eight weeks and will be planned according to the availability of volunteers. In each session, it will be recorded if any type of adverse effect occurs. There will be four types of interventions: i. Visual Illusion (IV) and therapeutic exercise program (PE), ii.placebo and PE, iii. IV, iv. IV placebo.
详细描述
Approximately 60% of people with a spinal cord injury have an incomplete injury. This causes alterations in strength, sensitivity, and muscle tone, which leads to a marked loss of functionality. This supposes a profound psychological and socioeconomic impact on the life of the affected person, in addition to the implicit physical impact.
After an injury of this type, there is a spontaneous functional recovery that may have a different path depending on the characteristics of the injury and the person. Previous studies have shown that the neuroplasticity of the residual corticospinal fibers, the motor cortex, and the spinal neurons play an important role in the spontaneous functional recovery of people with neurological or musculoskeletal pathology. However, it is also possible to stimulate the neuroplasticity mechanisms of these structures through techniques aimed at rehabilitating different deficits (for example, motor function or sensitivity). In general, intervention programs are usually carried out, in most cases, using low-cost strategies such as therapeutic physical exercise programs.
This nervous reorganization and recovery can also be influenced by the activity of mirror neurons, which are found in motor and premotor areas and also in other cortical and subcortical areas; and they report activation when they observe an action with a specific purpose. The activity of these neurons has been studied in different populations with involvement of the nervous and musculoskeletal system, such as cerebrovascular accidents, head injuries, Parkinson's, Alzheimer's, or carpal tunnel syndrome. For its study, experimental investigations have been carried out applying different interventions that modify the activity of mirror neurons, such as mirror therapy, virtual reality therapies, or Action-Observation therapies. Of these, in general, promising results have been obtained in all these populations, except in the case of Alzheimer's disease in an advanced stage.
However, these treatments have not been investigated in the recovery of the upper limb in people with incomplete spinal cord injury.
For all the above, the objective of this study is to analyze the effectiveness of visual illusion therapies in combination with conventional exercises on the symptoms and signs related to different pathologies of the nervous and musculoskeletal systems that affect the upper limb. Specifically, it is intended to know the impact of visual illusion therapy on:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incomplete cervical spinal cord injury (AIS C, D or E).
- •Ability to understand instructions (Mini-Mental State Examination> 23 points)
排除标准
- •Traumatic pathology in upper limbs.
- •Other alterations of the central nervous system or peripheral
- •Alterations in the vestibular system.
- •Concomitant diseases.
研究组 & 干预措施
VI sham
干预措施: Sham Visual illusion (Other)
VI sham and EP
the configuration of the work table will be the same as in real IV, although videos of landscapes will be projected on them without any type of human or animal movement appearing on them. This program will last 10 minutes. Afterwards, a physical exercise program for the upper extremities will be carried out, detailed in Arm I.
干预措施: Sham Visual illusion (Other)
Visual Illusion (VI and therapeutic exercise program (EP)
the patient will be seated in a chair with a table in front of it. The front part of the trunk will be covered with a black blanket that will be attached to the table. On the table, you will see arms and hands projected performing different types of functional manual activities that will include mobility and strength tasks. The projected arms will be adapted to the dimensions of each subject so that the patient can recognize the projected arms as theirs. This program will last 10 minutes. Then a physical exercise program for the upper extremities will be carried out:
- General mobility and warm-up: flexion-extension joint movements, rotations, deviations, abduction-adduction, etc.
- Gross mobility and coordination: ball games.
- Fine mobility and coordination: writing tasks, puzzles, abacus ...
- Strength exercises: shoulder, elbow, wrist, fingers.
- Stretching.
干预措施: Visual illusion (Other)
Visual Illusion (VI and therapeutic exercise program (EP)
the patient will be seated in a chair with a table in front of it. The front part of the trunk will be covered with a black blanket that will be attached to the table. On the table, you will see arms and hands projected performing different types of functional manual activities that will include mobility and strength tasks. The projected arms will be adapted to the dimensions of each subject so that the patient can recognize the projected arms as theirs. This program will last 10 minutes. Then a physical exercise program for the upper extremities will be carried out:
- General mobility and warm-up: flexion-extension joint movements, rotations, deviations, abduction-adduction, etc.
- Gross mobility and coordination: ball games.
- Fine mobility and coordination: writing tasks, puzzles, abacus ...
- Strength exercises: shoulder, elbow, wrist, fingers.
- Stretching.
干预措施: Physical exercise (Other)
VI sham and EP
the configuration of the work table will be the same as in real IV, although videos of landscapes will be projected on them without any type of human or animal movement appearing on them. This program will last 10 minutes. Afterwards, a physical exercise program for the upper extremities will be carried out, detailed in Arm I.
干预措施: Physical exercise (Other)
VI
only the visual illusion program will be carried out, detailed in Arm I.
干预措施: Visual illusion (Other)
结局指标
主要结局
Range of motion of elbow
时间窗: 7 minutes.
Nedcodo Agile was used to assess this outcome. Nedcodo Agile is a newly developed tool by Institut de Biomecànica de València (IBV) that measures elbow and wrist range of movement in degrees of range of movement, and press force in newtons.
Upper limb isometric force.
时间窗: 10 minutes
A load cell (CTCS; Mutronic) is used to assess upper limb muscles force (in Newtons).
Spasticity of upper limb
时间窗: 2 minutes
Modified Ashworth Scale (from 1 to 4): 0: No increase in muscle tone. 1: Slight increase in muscle tone, with a catch and release or minimal resistance at the end of the range of motion when an affected part(s) is moved in flexion or extension. 1+: Slight increase in muscle tone, manifested as a catch, followed by minimal resistance through the remainder (less than half) of the range of motion. 2: A marked increase in muscle tone throughout most of the range of motion, but affected part(s) are still easily moved. 3: Considerable increase in muscle tone, passive movement difficult. 4: Affected part(s) rigid in flexion or extension..
Range of motion of wrist
时间窗: 7 minutes.
Nedcodo Agile was used to assess this outcome. Nedcodo Agile is a newly developed tool by Institut de Biomecànica de València (IBV) that measures elbow and wrist range of movement in degrees of range of movement, and press force in newtons.
Fingers coordination.
时间窗: 7 minutes.
Hand assessment tablet app is a tool developed by Neurorehabilitation and Brain research group that assesses hand coordination and dexterity. This app counts the number of taps in a determined time and their velocity.
Rang of movement of gripper.
时间窗: 7 minutes.
Hand assessment tablet app is a tool developed by Neurorehabilitation and Brain research group that assesses hand coordination and dexterity. This app measure the range of gripper of each finger.
Graphomotricity.
时间窗: 7 minutes.
Hand assessment tablet app is a tool developed by Neurorehabilitation and Brain research group that assesses hand coordination and dexterity. This app measure the error in centimeters of graphomotricity activity.
Muscle tone of upper limb. Natural Oscillation Frequency.
时间窗: 5 minutes
MyotonPRO is used to assess tone or state of tension (Natural Oscillation Frequency \[Hz\]) of upper limb muscles.
Muscle tone of upper limb. Biomaechanical properties.
时间窗: 5 minutes
MyotonPRO is used to assess biomaechanical properties (Dynamic Stiffness \[N/m\], Logarithmic Decrement of natural oscillation, characterizing and Elasticity) of upper limb muscles.
Muscle tone of upper limb. Viscoelastic properties
时间窗: 5 minutes
MyotonPRO is used to assess viscoelastic properties (Mechanical Stress Relaxation Time \[ms\], Ratio of deformation and Relaxation time, characterising Creep (Deborah number)) of upper limb muscles.
Muscle activation.
时间窗: 10 minutes.
The BTS FreeEMG Electromyograph is used to assess upper limb muscles activation (in microV).
Severity of pain and degree of interference with feeling and function.
时间窗: 5 minutes
Brief Pain Inventory is used to assess neuropathic pain. This test measures pain severity and pain interference from 0 to 10.
次要结局
- Propioception(5 minutes)
- Independence(5 minutes)
- Quality of life index- Spinal cord injury(8 minutes)
- Press force (Newtons)(7 minutes)
研究者
Pilar Serra Añó
Professor of Physiotherapy
University of Valencia